Method for manufacturing medicated chewing gum without cooling

ABSTRACT

An improved method for manufacture of chewing gums containing active ingredient(s) that preserves the efficacy of the active ingredient(s) by avoiding exposure to high heat and extreme cold during milling that can otherwise degrade the active&#39;s efficacy. A chewing gum base is used, along with one or more therapeutically-active ingredients, one or more sweeteners (alcohol-based and/or natural), and one or more flavorings and optional flavor modifiers. The method generally comprises heating the gum base in ovens to melt the gum base. Separately, the active ingredient(s), sweeteners and flavorings are combined in a mixer. The melted gum base is added to the mixer and cools to produce a particulate mixture. As mixing continues the mass cools to room temperature and forms granular pieces. The granular pieces are ground into a powder at room temperature, mixed at room temperature with tableting excipients, and tableted. Several variations on the foregoing are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

In accordance with 37 CFR § 1.76, a claim of priority is included in anApplication Data Sheet filed concurrently herewith. Accordingly, thepresent invention claims priority as a divisional of U.S. patentapplication Ser. No. 14/732,072, entitled “METHOD FOR MANUFACTURINGMEDICATED CHEWING GUM WITHOUT COOLING”, filed Jun. 5, 2015, which claimspriority to U.S. Provisional Patent Application No. 62/008,211, filedJun. 5, 2014.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to the manufacture of chewinggums containing active ingredients and, more specifically, to a methodfor manufacture of such chewing gums that preserves the efficacy of theactive ingredient(s).

2. Description of the Background

The conventional methods of producing compressible chewing gums entailfreezing the gum base and then grinding to obtain a particulatematerial, mixing the particulate material with other materials (usuallyin particulate form), then pressing the compressible chewing gum mixtureinto tablets.

For example, U.S. Pat. No. 4,370,350 to Fisher et al. (Wrigley) issuedJan. 25, 1983 shows a method for the manufacture of chewing gum in whichthe viscosity of the gum base is first reduced by heating. A bulkingagent is then added to the gum base while mixing. The mixture is cooledduring mixing to form granules. More bulking agent is added to formlayers around the granules, and there is no active ingredient nor anygrinding or tableting.

For example, U.S. Pat. No. 7,101,579 to Athanikar et al. (Deseret Labs)issued Sep. 5, 2006 shows a chewing gum composition containing an activeingredient. The gum base is cooled to a temperature at which thecomposition is brittle, ground, mixed with the active ingredient asdesired, and formed into a tablet.

U.S. Pat. No. 5,711,961 to Reiner et al. (APR Applied Pharma) issuedJan. 27, 1998 discloses a pharmaceutical chewing gum composition intablet form made by freezing, grinding the gum in a mill, andgranulating the ground gum in a fluid bed. Thereafter, a medicinalactive agent is mixed with the granulate, and the granulates arecompressed into tablets. This patent is provided for general interest.

U.S. Pat. No. 4,975,270 to Kehoe (Nabisco) issued 4 Dec. 1990 shows amedicament-active chewing gum made by freezing and grinding into aparticle. Note that the gum and the active ingredient are mixed togetherwhile heating, and then the mixture is frozen and ground into particles.

U.S. Pat. No. 6,582,738 to Gubler (Deseret Laboratories) issued Jun. 24,2003 shows a process for preparing chewing gum containing a nutritionalsupplement that includes cooling and grinding the cooled, brittle gumcomposition to form a chewing gum powder, mixing with an activenutritional supplement, granulating, and then compressing the granulesto form chewing gum tablets. The chewing gum composition is cooled to atemperature at which the gum composition is brittle.

Alternatively it is known to mix a powder sweetener into a molten gumbase while subjecting the mixture to shear (i.e., through the mixingforce) and cooling. This technique causes the grinding as the mixturebecomes more rigid due to cooling and the addition of the dry sweetener.

U.S. Pat. No. 4,753,805 to Cherukuri et al. (Warner-Lambert) issued Jun.28, 1988 shows a tabletted chewing gum composition and method ofpreparation in which a gum base is mixed with a sweetener, and themixture is ground with an abrasive grinding aid (alkali metalphosphates, alkaline earth metal phosphates, maltodextrins).

U.S. Pat. No. 7,208,186 (SPI Pharma, Inc.) to Norman et al. issued Apr.24, 2007 shows a chewing gum formulation with an active ingredient. Thegum base, granulating agent and a processing aid are mixed until inparticulate form. The temperature in the mixer is then increased to atemperature which is sufficient to melt at least the surface of the gumbase particles and the contents of the mixer are mixed for severalminutes at this temperature to obtain a uniform mixture of the gum base,the granulating agent and the processing aid in particulate formparticles inside the mixer. Next, the active ingredient is added to theparticles and most or all of the active ingredient is loosely bound tothe outer surfaces of the particles. The particles are tableted. Thereis no cooling necessary to make the chewing gum formulation friable.

U.S. Pat. No. 7,351,438 to Sozzi et al. (Gum Base Co., SPA) issued Apr.1, 2008 shows a method of preparing chewing gum in tablet form by directcompression of the chewing gum formulation in powder form. The chewinggum in powder form is produced by a method which comprises the followingsteps:

a) mixing of a soft basic gum with at least one sweetener and,optionally, at least one other typical chewing-gum ingredient, at atemperature of between 35 and 75° C., b) cooling of the mixture thusobtained to a temperature of between 0 and −40° C. and preferablybetween −10 and −40° C.,

-   -   c) grinding and subsequent screening of the mixture thus        obtained to a particle size of less than 10 mesh,    -   d) optional mixing of the powder thus obtained with at least one        anti-agglutination agent, e) optional compression of the mixture        thus obtained.

U.S. Pat. No. 5,866,179 to Testa (Avant-Garde Technologies) issued Feb.2, 1999 shows a medicated chewing gum and a process for preparationthereof in which the active agent is mixed with a granulated gum baseunder controlled temperature and humidity and the blended components arecold-pressed to produce a final gum product. The gum base is prepared bycooling natural gum to −10 degree C., then grinding it. It is noted thatthe elevated temperatures used in the melt can adversely affect thechemical stability of the therapeutic agent.

Neither prior method is optimal for chewing gums with active ingredientssince heating and/or cooling can erode the effectiveness of the active.The proposed process avoids this by initially heating a gum base toslightly elevated internally measured temperature between 140-160 deg F.in ovens, mixing with the active as it cools to produce a particulatemixture, grinding into compressible powder, then forming into tablets.The temperature of the gum base exceeds that of the mixer when firstintroduced, but as mixing continues it cools and mixes into aparticulate form inside the mixer. Next, the particulate is ground intocompressible powder at room temperature, mixed at room temperature withexcipients, and tableted. This avoids heating/cooling of the active andpreserves its efficacy.

SUMMARY OF THE INVENTION

It is an object of the invention to provide an improved method formanufacture of chewing gums containing active ingredients that preservesthe efficacy of the active ingredient(s).

It is another object to provide a method for manufacture of chewing gumscontaining active ingredients that avoids exposure of the activeingredients to high heat during mixing that can degrade the active'sefficacy.

It is another object to provide a method for manufacture of chewing gumscontaining active ingredients that avoids exposure of the activeingredients to extreme cold during milling that can degrade the active'sefficacy.

It is another object to provide a method for manufacture of chewing gumscontaining active ingredients in which the active in oil form can bemixed directly into the other powder ingredients and tableted, ratherthan spray-dried onto a powder carrier for tableting as with the priorart methods. This direct mixing of the oil into the powder can delivermore active ingredient with less weight than the alternatives thusmaking the tableting process more efficient and less expensive

In accordance with the foregoing objects, present invention provides animproved method for manufacture of chewing gums containing activeingredients that preserves the efficacy of the active ingredient(s) byavoiding exposure to high heat and extreme cold during milling that canotherwise degrade the active's efficacy. A suitable chewing gum base isused preferably comprising one or more constituents including elastomersfor elasticity, resins to act as binders and softeners, plasticizers torender the elastomer soft to ensure thorough blending of the gum base,fillers contributing to the overall texture, and antioxidants to preventoxidation of the gum base and flavors during shelf life. In addition,one or more therapeutically-active ingredients are used, one or moresweeteners (alcohol-based and/or natural), and one or more flavoringsand optional flavor modifiers are used.

Generally, the method comprises initially heating the gum base in ovensto melt the gum base to an internally measured temperature between140-160 deg F. Separately, powdered ingredients including one or moreactive ingredient(s), sweeteners and flavorings are combined in a mixer.The melted gum base is added to the mixer and cools to produce aparticulate mixture. The temperature of the gum base exceeds that of themixer when first introduced, but as mixing continues it cools quickly toroom temperature and forms granular pieces. The granular pieces areconditioned for a period of time. Conditioning is the time between themixing and grinding of the gum. Conditioning allows the granular piecesto dry slightly and complete the crystallization process. Next, thegranular pieces are ground into a powder at room temperature, mixed atroom temperature with tableting excipients, and tableted. This processavoids extreme heating or cooling of the active ingredient(s) andpreserves the efficacy.

The present invention including several embodiments is described ingreater detail in the detailed description of the invention, and theappended drawings. Additional features and advantages of the inventionwill be set forth in the description that follows, will be apparent fromthe description, or may be learned by practicing the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, features, and advantages of the present invention willbecome more apparent from the following detailed description of thepreferred embodiments and certain modifications thereof when takentogether with the accompanying drawings in which:

FIG. 1 is a process flow diagram of a first embodiment of the method formanufacturing chewing gum according to the invention, suited for activeingredient(s) that are provided in powder form.

FIG. 2 is a process flow diagram of a second embodiment of a method formanufacturing chewing gum according to the invention, likewise suitedfor active ingredient(s) that are provided in powder form.

FIG. 3 is a process flow diagram of a third embodiment of the method formanufacturing chewing gum according to the invention, suited for activeingredient(s) that are provided in oil form.

FIG. 4 is a process flow diagram of a fourth embodiment of the methodfor manufacturing chewing gum according to the invention, suited foractive ingredient(s) that are provided in oil form.

FIG. 5 is a process flow diagram of a fifth embodiment of the method formanufacturing chewing gum according to the invention, suited for activeingredient(s) that are provided in oil form.

FIG. 6 is a flow diagram of a sixth embodiment of the method formanufacturing chewing gum according to the invention, suited for activeingredient(s) that are provided in oil form.

FIG. 7 is a process flow diagram of a seventh embodiment of the methodfor manufacturing chewing gum according to the invention, suited foractive ingredient(s) that are provided in oil form.

FIG. 8 is a flow diagram of a eighth embodiment of the method formanufacturing chewing gum according to the invention, suited for activeingredient(s) that are provided in oil form.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Reference will now be made in detail to preferred embodiments of thepresent invention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

For purposes of description, the term “active” is herein defined as theingredient or ingredients that provide a therapeutic effect. In thepresent invention active(s) may be provided in either powder or oilform. An active in oil form is defined as a free flowing liquid,semi-solid, or paste that is lipid-based and not water soluble. In thecase of a semi-solid or paste, when heated to a maximum temperature of140 deg F., the material changes to an oil. Active ingredients in oilform can include hemp oil, THC resin, any cannabinoid oil, as well aspharmaceutical actives, botanicals and essential oils.

The invention generally is an improved method for manufacture of chewinggums containing active ingredients that preserves the efficacy of theactive ingredient(s) by avoiding exposure to high heat and extreme cold,mainly during milling, that can otherwise degrade the active's efficacy.A suitable chewing gum base is used comprising one or more constituentsincluding elastomers for elasticity, resins to act as binders andsofteners, plasticizers to render the elastomer soft to ensure thoroughblending of the gum base, fillers contributing to the overall texture,and antioxidants to prevent oxidation of the gum base and flavors duringshelf life.

Generally, the method comprises initially heating the gum base in ovensto melt the gum base to an internally measured temperature between140-160 deg F. Ingredients, including one or more active ingredient(s),are combined in a mixer. The melted gum base is added to the mixer andcools to produce a particulate mixture. The temperature of the gum baseexceeds that of the mixer when first introduced, but as mixing continuesit cools quickly to room temperature and forms rock-sized granularpieces. These granular pieces are then conditioned for a period of time,which allows the granular pieces to dry slightly and complete thecrystallization process. Preferably, the pieces are conditioned for atleast 6 hours at a temperature not greater than 75 deg. F. and 60%relative humidity. Next, the pieces are ground into a powder at roomtemperature, mixed at room temperature with tableting excipients, andtableted. This avoids extreme heating or cooling of the activeingredient(s) and preserves the efficacy.

The active ingredients may be provided in raw powder or oil form, andthe present application suggests two alternative methods one suited forthe powder form and one for the oil form. When the active ingredient(s)is in oil form, the oil can be mixed directly into the other powderingredients and tableted, and there is no need for spray-drying the oilonto a powder carrier for tableting as with the prior art methods. Thisdirect mixing delivers more active ingredient with less weight thusmaking the tableting process more efficient and less expensive.

FIG. 1 is a flow diagram of the method for manufacturing chewing gumaccording to an embodiment of the invention suited for activeingredient(s) in powder form.

At step 105 one or more different gum base(s) are placed in trays linedwith a sugar alcohol and the trays are placed in an oven. The gum baseis melted until it reaches an internally measured temperature between140-160 deg F. Temperature may be measured with a commercial foodthermometer.

At step 100, in a commercial mixer, preferably a double Z-blade mixer(for example, a WINKWORTH® double blade Z blender), the activeingredient(s), the sugar alcohols, flavors and flavor modifiers areadded and mixed approximately 3 to 7 minutes.

At step 110 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 120 the mass is removed from the blender and conditioned intrays for a minimum of 6 hours at a temperature not greater than 75 degF. and 60% relative humidity.

At step 130, after the conditioning period, the gum is milled intoparticulates at room temperature using a hammer mill that forces theparticulates through a mesh screen of appropriate predetermined particlesize ranging between 0.10 inch to 0.30 inch with an optimal size of 0.24inch.

Optionally, at step 135 other active ingredients, flavor modifiers, orthe like may be added.

At step 140 the resulting powder is placed in an orbital or planetarymixer and the flow agents and tablet lubricants are added. The powder isblended for approximately 2 to 4 minutes.

At step 150 the powder is tableted using standard tablet punches on anysuitable commercial tablet press.

The foregoing method entirely avoids exposure of the active ingredientto high heat or extreme cold during milling that would otherwise degradethe active's efficacy.

FIG. 2 is a flow diagram of the method for manufacturing chewing gumaccording to another embodiment of the invention, also suited for activeingredient(s) in powder form.

At step 205 one or more different gum base(s) are placed in trays linedwith a sugar and the trays are placed in an oven. The gum base is melteduntil it reaches an internally measured temperature between 140-160 degF.

At step 200, in a commercial mixer, preferably a double Z-blade mixer(for example, a Winkworth® double blade Z blender), the activeingredient(s), the sugars, flavors and flavor modifiers are added andmixed approximately 3 to 7 minutes.

At step 210 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 220 the mass is removed from the blender and conditioned intrays for a minimum of 6 hours at a temperature not greater than 75 degF. and 60% relative humidity.

At step 230, after the conditioning period, the gum is milled intoparticulates at room temperature using a hammer mill that forces theparticulates through a mesh screen of appropriate particle size rangingbetween 0.10 inch to 0.30 inch with an optimal size of 0.24 inch.

Optionally, at step 235 other active ingredients, flavor modifiers, orthe like may be added.

At step 240 the resulting powder is placed in an orbital or planetarymixer and the flow agents and tablet lubricants are added. The powder isblended for approximately 2 to 4 minutes.

At step 250 the powder is tableted using standard tablet punches on anysuitable commercial tablet press.

The foregoing method entirely avoids exposure of the active ingredientto high heat or extreme cold during milling that would otherwise degradethe active's efficacy.

FIG. 3 is a flow diagram of a method for manufacturing chewing gumaccording to an alternate embodiment of the invention suited for activeingredient(s) that are provided in oil form.

At step 305 a pre-mix consisting of the active(s) and a portion of thesweeteners comprising approximately 9 to 13% of one or more sugaralcohols (see Table 1, 3, 5, 6 below) are mixed in a suitable commercialorbital mixer. These ingredients are mixed approximately 3 to 9 minutes,until a homogeneous mix is obtained.

Separately, at step 300 in a double blade Z blender, the balance of thesweeteners (the remaining 87-91% of the sugar alcohol(s), plus theflavors and flavor modifiers are added and mixed approximately 3 to 7minutes.

At step 310 the premix containing the active oil(s) is added to theblender and is mixed approximately 2 to 5 minutes.

At step 315 one or more different gum base(s) are placed in trays linedwith a sugar alcohol and the trays are placed in an oven. The gum baseis melted until it reaches an internally measured temperature between140-160 deg F.

At step 320 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 330 the mass is removed from the blender and conditioned intrays for a minimum of 6 hours at a temperature not greater than 75 degF. and 60% relative humidity.

At step 340, after the conditioning period, the gum is milled intoparticulates at room temperature using a hammer mill that forces theparticulates through a mesh screen of appropriate pre-determinedparticle size ranging between 0.10 inch to 0.30 inch with an optimalsize of 0.24 inch.

Optionally, at step 345 flavor modifiers may be added.

At step 350 the resulting powder is placed in an orbital or planetarymixer and the flow agents and tablet lubricants are added. The powder isblended for approximately 2 to 4 minutes.

At step 360 the powder is tableted using standard tablet punches on anysuitable commercial tablet press.

As above this method entirely avoids exposure of the active ingredientto high heat or extreme cold during milling that would otherwise degradethe active's efficacy.

FIG. 4 is a flow diagram of a method for manufacturing chewing gumaccording to an alternate embodiment of the invention suited for activeingredient(s) that are provided in oil form.

At step 405 a pre-mix consisting of the active(s) and a portion of thesweeteners comprising approximately 9 to 13% of one or more sugars (seeTables 2, 4 below) are mixed in a suitable commercial orbital mixer.These ingredients are mixed approximately 3 to 9 minutes, until ahomogeneous mix is obtained.

Separately, at step 400 in a double blade Z blender, the balance of thesugars (the remaining 87-91%), plus flavors and flavor modifiers areadded and mixed approximately 3 to 7 minutes.

At step 410 the premix containing the active oil(s) is added to theblender and is mixed approximately 2 to 5 minutes.

At step 415 one or more different gum base(s) are placed in trays linedwith a sugar and the trays are placed in an oven. The gum base is melteduntil it reaches an internally measured temperature between 140-160 degF.

At step 420 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 430 the mass is removed from the blender and conditioned intrays for a minimum of 6 hours at a temperature not greater than 75 degF. and 60% relative humidity.

At step 440, after the conditioning period, the gum is milled intoparticulates at room temperature using a hammer mill that forces theparticulates through a mesh screen of appropriate particle size rangingbetween 0.10 inch to 0.30 inch with an optimal size of 0.24 inch.

Optionally, at step 445 flavor modifiers may be added.

At step 450 the resulting powder is placed in an orbital or planetarymixer and the flow agents and tablet lubricants are added. The powder isblended for approximately 2 to 4 minutes.

At step 460 the powder is tableted using standard tablet punches on anysuitable commercial tablet press.

As above this method entirely avoids exposure of the active ingredientto high heat or extreme cold during milling that would otherwise degradethe active's efficacy.

FIG. 5 is a flow diagram of a method for manufacturing chewing gumaccording to an alternate embodiment of the invention suited for activeingredient(s) that are provided in oil form.

At step 505 a pre-mix consisting of the active(s) and a portion of thetotal sweeteners, e.g., approximately 9 to 13% of one or more of sugaralcohol, microcrystalline cellulose, dextrose, modified starch, starchderivatives or other liquisolid system (see Table 1, 3, 5, 6 below) aremixed in a suitable commercial orbital mixer. These ingredients aremixed approximately 3 to 9 minutes, until a homogeneous mix is obtained.

Separately, at step 500 in a double blade Z blender, the balance of thesugar alcohols (the remaining 87-91% of the sugar alcohol(s), plus theentirety of the flavors and flavor modifiers are added and mixedapproximately 3 to 7 minutes.

At step 510 the premix containing the active oil(s) is added to theblender and is mixed approximately 2 to 5 minutes.

At step 515 one or more different gum base(s) are placed in trays linedwith a sugar alcohol and the trays are placed in an oven. The gum baseis melted until it reaches an internally measured temperature between140-160 deg F.

At step 520 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 530 the mass is removed from the blender and conditioned intrays for a minimum of 6 hours at a temperature not greater than 75 degF. and 60% relative humidity.

At step 540, after the conditioning period, the gum is milled intoparticulates at room temperature using a hammer mill that forces theparticulates through a mesh screen of appropriate particle size rangingbetween 0.10 inch to 0.30 inch with an optimal size of 0.24 inch.

Optionally, at step 545 flavor modifiers may be added.

At step 550 the resulting powder is placed in an orbital or planetarymixer and the flow agents and tablet lubricants are added. The powder isblended for approximately 2 to 4 minutes.

At step 560 the powder is tableted using standard tablet punches on anysuitable commercial tablet press.

As above this method entirely avoids exposure of the active ingredientto high heat or extreme cold during milling that would otherwise degradethe active's efficacy.

FIG. 6 is a flow diagram of a method for manufacturing chewing gumaccording to an alternate embodiment of the invention suited for activeingredient(s) that are provided in oil form.

At step 600 in a double blade Z blender, the sugar alcohols, flavors andflavor modifiers are added and mixed approximately 3 to 7 minutes, andthe active oil(s) is added to the blender and is mixed approximately 2to 5 minutes.

At step 605 one or more different gum base(s) are placed in trays linedwith a sugar alcohol and the trays are placed in an oven. The gum baseis melted until it reaches an internally measured temperature between140-160 deg F.

At step 610 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 620 the mass is removed from the blender and conditioned intrays for a minimum of 6 hours at a temperature not greater than 75 degF. and 60% relative humidity.

At step 630, after the conditioning period, the gum is milled intoparticulates at room temperature using a hammer mill that forces theparticulates through a mesh screen of appropriate particle size rangingbetween 0.10 inch to 0.30 inch with an optimal size of 0.24 inch.

At step 635 a pre-mix consisting of the active(s) and approximately 9 to13% of a portion of the sweeteners, e.g., one or more of sugar alcohol,microcrystalline cellulose, dextrose, modified starch, starchderivatives or other liquisolid systems (see Table 1, 3, 5, 6 below) aremixed in a suitable commercial orbital or planetary mixer. Theseingredients are mixed approximately 3 to 9 minutes, until a homogeneousmix is obtained.

At step 640 the resulting powder is placed in an orbital or planetarymixer, the flow agents and any flavor modifiers are added. The powder isblended for approximately 3 to 8 minutes.

At step 650 the milled gum powder is placed in an orbital or planetarymixer and the pre-mix and tablet lubricants are added. The powder isblended for approximately 3 to 5 minutes.

At step 660 the powder is tableted using standard tablet punches on anysuitable commercial tablet press.

As above this method entirely avoids exposure of the active ingredientto high heat or extreme cold during milling that would otherwise degradethe active's efficacy.

FIG. 7 is a flow diagram of a method for manufacturing chewing gumaccording to an alternate embodiment of the invention suited for activeingredient(s) that are provided in oil form.

At step 700 in a double blade Z blender, the sugar alcohols, flavors andflavor modifiers are added and mixed approximately 3 to 7 minutes.

At step 705 one or more active oil(s) is/are added to the blender andare mixed approximately 2 to 5 minutes.

At step 710 one or more different gum base(s) are placed in trays linedwith a sugar alcohol and the trays are placed in an oven. The gum baseis melted until it reaches an internally measured temperature between140-160 deg F.

At step 720 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 730 the mass is removed from the blender and conditioned intrays for a minimum of 12 hours.

At step 740, after the conditioning period, the gum is extruded througha die to form the desired shape of the gum.

Optionally, at step 750 a coating of a sugar alcohol can be applied tothe gum piece.

FIG. 8 is a flow diagram of a method for manufacturing chewing gumaccording to an alternate embodiment of the invention suited for activeingredient(s) that are provided in oil form.

At step 800 a pre-mix consisting of the active(s) and a portion of thetotal sweeteners, e.g., approximately 9 to 13% of one or more of sugaralcohol, liquid flavors, microcrystalline cellulose, dextrose, modifiedstarch, starch derivatives or other liquisolid system (see Table 1, 3,5, 6 below) are mixed in a suitable commercial orbital mixer. Theseingredients are mixed approximately 3 to 9 minutes, until a homogeneousmix is obtained. Separately, at step 805 in a double blade Z blender,the balance of the sugar alcohols (the remaining 87-91% of the sugaralcohol(s), plus the flavors and flavor modifiers are added and mixedapproximately 3 to 7 minutes.

At step 810 the premix containing the active oil(s) is added to theblender and is mixed approximately 2 to 5 minutes.

At step 815 one or more different gum base(s) are placed in trays linedwith a sugar alcohol and the trays are placed in an oven. The gum baseis melted until it reaches an internally measured temperature between140-160 deg F.

At step 820 the melted gum base is added into the mixer and mixed untila homogeneous mass is produced. The mixing time may vary within a rangeof from 2 to 6 minutes.

At step 830 the mass is removed from the blender and conditioned intrays for a minimum of 12 hours.

At step 840, after the conditioning period, the gum is extruded througha die to form the desired shape of the gum.

Optionally, at step 845 a coating of a sugar alcohol can be applied tothe gum piece.

As above this method entirely avoids exposure of the active ingredientto high heat or extreme cold that would otherwise degrade the active'sefficacy.

The following examples provide specific ingredient listings including arange of acceptable weight % and preferred weight % for ingredients usedin the above-described processes for manufacturing particular gumshaving maximum efficacy.

Example 1: Chitosan Chewing Gum

The foregoing method of FIG. 1 has been used successfully to produce atableted gum with a powdered active ingredient, for example chitosan,using the relative amounts of constituents (sugar alcohol, gum base,flavoring, active ingredient/chitosan, tableting lubricants and powderflow agents, and sweeteners) as shown in Table 1:

TABLE 1 Weight % Optimal Range Weight % A sugar alcohol or a blend ofsugar alcohols 42.4-75.3  64.0 that can include one or more of thefollowing: sorbitol, isomalt, xylitol, maltitol, mannitol or erythritolGum Base 20.0-30.0  25.7 Flavoring in liquid and powder  2.0-12.0  3.3Active ingredient(s)—chitosan  1.0-20.0  2.5 Tableting lubricants andpowder flow agents  1.5-5.0  4.0 Intensive sweeteners  0.2-0.6  0.5Total 100.0

Example 2: Caffeine Chewing Gum

The foregoing method of FIG. 2 has been used successfully to produce atableted gum with a powdered active ingredient, for example caffeine,using the relative amounts of constituents (sugar, gum base, flavoring,active ingredient/caffeine, tableting lubricants and powder flow agents,and sweeteners) as shown in Table 2:

TABLE 2 Weight % Optimal Range Weight % A sugar or a blend of sugarsthat can include 55.0-70.0  59.6 one or more of the following: dextrose,sucrose, fructose, glucose Gum Base 20.0-30.0  21.2 Flavoring in liquidand powder  8.0-15.0  9.8 Active ingredient(s)—caffeine  1.0-10.0  4.7Tableting lubricants and powder flow agents  2.6-5.0  3.7 Intensivesweeteners  0.2-1.5  1.0 Total 100.0

Example 3: Hemp Oil Chewing Gum

The foregoing method of FIG. 3 has been used successfully to produce atableted gum with an oil-form active ingredient, for exampleconcentrated hemp oil that delivers cannabidiol (CBD) or with a resinousoil that delivers tetrahydrocannabinol (THC). The relative amounts ofconstituents (sugar alcohol, gum base, flavoring, active ingredient/hempoil, tableting lubricants and powder flow agents, and sweeteners) asshown in Table 3:

TABLE 3 Weight % Optimal Range Weight % A sugar alcohol or a blend ofsugar alcohols 48.4-68.8  57.8 that can include one or more of thefollowing: sorbitol, isomalt, xylitol, maltitol, mannitol or erythritolGum Base 20.0-30.0  28.5 Flavoring in liquid and powder  9.0-11.0  6.9Active ingredient(s)—hemp oil  0.5-10.0  2.5 Tableting lubricants andpowder flow agents  1.5-5.0  3.8 Intensive sweeteners  0.2-0.6  0.5Total 100.0

Example 4: Hemp Oil Chewing Gum

The foregoing method of FIG. 4 has been used successfully to produce atableted gum with an oil-form active ingredient, for exampleconcentrated hemp oil that delivers cannabidiol (CBD) or with a resinousoil that delivers tetrahydrocannabinol (THC). The relative amounts ofconstituents (sugars, gum base, flavoring, active ingredient/hemp oil,tableting lubricants and powder flow agents, and sweeteners) as shown inTable 4:

TABLE 4 Weight % Optimal Range Weight % A sugar or a blend of sugarsthat can include 53.0-70.0  62.9 one or more of the following: dextrose,sucrose, fructose, glucose Gum Base 20.0-30.0  28.6 Flavoring in liquidand powder  2.5-4.5  3.6 Active ingredient(s)—hemp oil  0.5-10.0  0.9Tableting lubricants and powder flow agents  1.5-5.0  3.5 Intensivesweeteners  0.2-0.6  0.5 Total 100.0

Example 5: Hemp Oil Chewing Gum

The foregoing method of FIG. 5 has been used successfully to produce atableted gum with an oil-form active ingredient, for exampleconcentrated hemp oil that delivers cannabidiol (CBD) or with a resinousoil that delivers tetrahydrocannabinol (THC). The relative amounts ofconstituents (sugar alcohol, cellulose/starch derivatives, gum base,flavoring, active ingredient/hemp oil, tableting lubricants and powderflow agents, and sweeteners) as shown in Table 5:

TABLE 5 Weight % Optimal Range Weight % A sugar alcohol or a blend ofsugar alcohols 48.4-68.8  57.8 that can include one or more of thefollowing: sorbitol, isomalt, xylitol, maltitol, mannitol or erythritoland one or more of the following: microcrystalline cellulose, dextrose,modified starch, starch derivatives or other liquidsolid system. GumBase 20.0-30.0  28.5 Flavoring in liquid and powder  5.0-11.0  6.9Active ingredient(s)—hemp oil  0.5-10.0  2.5 Tableting lubricants andpowder flow agents  1.5-5.0  3.8 Intensive sweeteners  0.2-0.6  0.5Total 100.0

Example 6: Hemp Oil Chewing Gum

The foregoing method of FIG. 6 has been used successfully to produce atableted gum with an oil-form active ingredient, for exampleconcentrated hemp oil that delivers cannabidiol (CBD) or with a resinousoil that delivers tetrahydrocannabinol (THC). The relative amounts ofconstituents (sugar alcohol, cellulose/starch derivatives, gum base,flavoring, active ingredient/hemp oil, tableting lubricants and powderflow agents, and sweeteners) as shown in Table 6:

TABLE 6 Weight % Optimal Range Weight % A sugar alcohol or a blend ofsugar alcohols 45.0-65.0  56.0 that can include one or more of thefollowing: sorbitol, isomalt, xylitol, maltitol, mannitol or erythritoland one or more of the following: microcrystalline cellulose, dextrose,modified starch, starch derivatives or other liquisolid system. Gum Base20.0-30.0  28.5 Flavoring in liquid and powder  5.0-11.0  9.0 Activeingredient(s)—hemp oil  0.5-10.0  2.5 Tableting lubricants and powderflow agents  1.5-5.0  3.5 Intensive sweeteners  0.2-0.6  0.5 Total 100.0

Example 7: Hemp Oil Chewing Gum

The foregoing method of FIG. 7 has been used successfully to produce agum with an oil-form active ingredient, for example concentrated hempoil that delivers cannabidiol (CBD) or with a resinous oil that deliverstetrahydrocannabinol (THC). The relative amounts of constituents (sugaralcohol, cellulose/starch derivatives, gum base, flavoring, activeingredient/hemp oil, and sweeteners) as shown in Table 7:

TABLE 7 Weight % Optimal Range Weight % A sugar alcohol or a blend ofsugar alcohols 45.0-65.0  55.5 that can include one or more of thefollowing: sorbitol, isomalt, xylitol, maltitol, mannitol or erythritolGum Base 25.0-40.0  33.0 Flavoring in liquid and powder  5.0-11.0  8.0Active ingredient(s)—hemp oil  0.5-10.0  3.0 Intensive sweeteners 0.2-0.6  0.5 Total 100.0

Example 8: Hemp Oil Chewing Gum

The foregoing method of FIG. 8 has been used successfully to produce agum with an oil-form active ingredient, for example concentrated hempoil that delivers cannabidiol (CBD) or with a resinous oil that deliverstetrahydrocannabinol (THC). The relative amounts of constituents (sugaralcohol, cellulose/starch derivatives, gum base, flavoring, activeingredient/hemp oil, and sweeteners) as shown in Table 8:

TABLE 8 Weight % Optimal Range Weight % A sugar alcohol or a blend ofsugar alcohols 45.0-65.0  55.5 that can include one or more of thefollowing: sorbitol, isomalt, xylitol, maltitol, mannitol or erythritoland one or more of the following: liquid flavor, microcrystallinecellulose, dextrose, modified starch, starch derivatives or otherliquisolid system. Gum Base 25.0-40.0  33.0 Flavoring in liquid andpowder  5.0-11.0  8.0 Active ingredient(s)—hemp oil  0.5-10.0  3.0Intensive sweeteners  0.2-0.6  0.5 Total 100.0

It should now be apparent that the above described method preserves theefficacy of the active ingredient(s) by avoiding exposure to high heatduring mixing, or to extreme cold during milling, either of which candegrade the active's efficacy. Moreover, the active ingredient(s) evenwhen provided in oil form can be mixed directly into the other powderingredients and tableted, rather than spray-dried onto a powder carrierfor tableting as with the prior art methods.

The foregoing disclosure of embodiments of the present invention hasbeen presented for purposes of illustration and description. It is notintended to be exhaustive or to limit the invention to the precise formsdisclosed. Many variations and modifications of the embodimentsdescribed herein will be obvious to one of ordinary skill in the art inlight of the above disclosure. The scope of the invention is to bedefined only by the claims, and by their equivalents.

1-24. (canceled)
 25. A composition comprising: a sugar alcohol, a blendof sugar alcohols, a sugar or blend of sugars, a gum base, flavoring,one or more active ingredients, tableting lubricants, powder flowagents, sweeteners and combinations thereof.
 26. The composition ofclaim 25, wherein the composition comprises: a sugar alcohol or a blendof sugar alcohols, a sugar, a blend of sugars and combinations thereof,from about 20% to about 90% by weight of the total weight of thecomposition; a gum base from about 10% to about 60% by weight of thetotal weight of the composition; a flavoring from about 0.1% to about30% by weight of the total weight of the composition; a tabletinglubricant and/or powder flow agents from about 0.1% to about 20% byweight of the total weight of the composition; an intensive sweetner(s)from about 0.01% to about 15% by weight of the total weight of thecomposition; an active ingredient from about 0.01% to about 40% byweight of the total weight of the composition; and, combinationsthereof.
 27. The composition of claim 26, wherein the compositioncomprises: a sugar alcohol, a blend of sugar alcohols, a sugar, a blendof sugars and combinations thereof, from about 40% to about 85% byweight of the total weight of the composition; a gum base from about 15%to about 35% by weight of the total weight of the composition; aflavoring from about 1% to about 25% by weight of the total weight ofthe composition; a tableting lubricant and/or powder flow agents fromabout 1% to about 10% by weight of the total weight of the composition;an intensive sweetner(s) from about 0.1% to about 10% by weight of thetotal weight of the composition; an active ingredient from about 1% toabout 30% by weight of the total weight of the composition; and,combinations thereof.
 28. The composition of claim 27, wherein thecomposition comprises: a sugar alcohol, a blend of sugar alcohols, asugar, a blend of sugars and combinations thereof, from about 40% toabout 80% by weight of the total weight of the composition; a gum basefrom about 15% to about 40% by weight of the total weight of thecomposition; a flavoring from about 1% to about 20% by weight of thetotal weight of the composition; a tableting lubricant and/or powderflow agents from about 0.5% to about 15% by weight of the total weightof the composition; an intensive sweetner(s) from about 0.1% to about 5%by weight of the total weight of the composition; an active ingredientfrom about 0.5% to about 30% by weight of the total weight of thecomposition; and, combinations thereof.
 29. The composition of claim 25,wherein the active ingredient is chitosan, caffeine, cannabidiol (CBD)or hemp oil.
 30. The composition of claim 25, wherein the sugar alcoholor the blend of sugar alcohols comprise sorbitol, isomalt, xylitol,maltitol, mannitol, erythritol and combinations thereof.
 31. Thecomposition of claim 25, wherein the sugar or the blend of sugarscomprises: dextrose, sucrose, fructose, glucose and combinationsthereof.
 32. The composition of claim 25, further comprising:microcrystalline cellulose, dextrose, modified starch, starchderivatives or other liquidsolid systems.
 33. A composition comprising:a sugar alcohol, a blend of sugar alcohols, a sugar or blend of sugars,a gum base, flavoring, one or more active ingredients, tabletinglubricants, powder flow agents, sweeteners, microcrystalline cellulose,dextrose, modified starch, starch derivatives or other liquidsolidsystem, and combinations thereof.
 34. The composition of claim 33,wherein the composition comprises: a sugar alcohol or a blend of sugaralcohols, microcrystalline cellulose, dextrose, modified starch, starchderivatives or other liquidsolid system, and combinations thereof fromabout 20% to about 80% by weight of the total weight of the composition;a gum base from about 10% to about 60% by weight of the total weight ofthe composition; a flavoring from about 1% to about 30% by weight of thetotal weight of the composition; a tableting lubricant and/or powderflow agents from about 0.1% to about 20% by weight of the total weightof the composition; an intensive sweetner(s) from about 0.01% to about10% by weight of the total weight of the composition; an activeingredient from about 0.01% to about 40% by weight of the total weightof the composition; and, combinations thereof.
 35. The composition ofclaim 34, wherein the composition comprises: a sugar alcohol, a blend ofsugar alcohols, a sugar, a blend of sugars, microcrystalline cellulose,dextrose, modified starch, starch derivatives or other liquidsolidsystem, and combinations thereof, from about 40% to about 85% by weightof the total weight of the composition; a gum base from about 15% toabout 55% by weight of the total weight of the composition; a flavoringfrom about 1% to about 25% by weight of the total weight of thecomposition; a tableting lubricant and/or powder flow agents from about1% to about 10% by weight of the total weight of the composition; anintensive sweetner(s) from about 0.1% to about 10% by weight of thetotal weight of the composition; an active ingredient from about 1% toabout 30% by weight of the total weight of the composition; and,combinations thereof.
 36. The composition of claim 35, wherein thecomposition comprises: a sugar alcohol, a blend of sugar alcohols, asugar, a blend of sugars, microcrystalline cellulose, dextrose, modifiedstarch, starch derivatives or other liquidsolid system, and combinationsthereof, from about 40% to about 75% by weight of the total weight ofthe composition; a gum base from about 15% to about 50% by weight of thetotal weight of the composition; a flavoring from about 1% to about 15%by weight of the total weight of the composition; a tableting lubricantand/or powder flow agents from about 0.5% to about 15% by weight of thetotal weight of the composition; an intensive sweetner(s) from about0.5% to about 7.5% by weight of the total weight of the composition; anactive ingredient from about 0.5% to about 20% by weight of the totalweight of the composition; and, combinations thereof.
 37. Thecomposition of claim 33, wherein the active ingredient is cannabidiol(CBD) or hemp oil.